A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

NCT05357755 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1091932021-005987-2377242113PSO2003
• Study Type: interventional
• Target: 90
• Locations: 6 countries
• Sites: 34

Brief Summary

The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentages of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 16

  Percentage of participants who achieved PASI-75 score (greater than or equal to \[\>=\] 75% improvement from baseline in PASI) at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.

  Baseline (Week 0), Week 16

Secondary Outcomes (8)

• Change From Baseline in PASI Total Score at Week 16

  Baseline (Week 0), Week 16

• Percentages of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI 90) Score at Week 16

  Baseline (Week 0), Week 16

• Percentages of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI 100) Score at Week 16

  Baseline (Week 0), Week 16

• Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

  Week 16

• Percentages of Participants Who Achieved an IGA Score of Cleared (0) at Week 16

  Week 16

Study Arms (3)

Group 1: JNJ-77242113 Dose 1

EXPERIMENTAL

Participants will receive JNJ-77242113 Dose 1 as delayed release tablets orally once daily from Week 0 through Week 16.

Drug: JNJ-77242113

Group 2: JNJ-77242113 Dose 2

EXPERIMENTAL

Participants will receive JNJ-77242113 Dose 2 as delayed release tablets orally once daily from Week 0 through Week 16.

Drug: JNJ-77242113

Group 3: Placebo

PLACEBO COMPARATOR

Participants will receive oral dose of matching placebo once daily from Week 0 through Week 16.

Drug: Placebo

Interventions

JNJ-77242113 DRUG

JNJ-77242113 will be administered orally as delayed release tablets.

Also known as: PN-21235,, PN-235

Group 1: JNJ-77242113 Dose 1; Group 2: JNJ-77242113 Dose 2

Placebo DRUG

Matching placebo will be administered orally as delayed release tablets.

Group 3: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
• Participant has a total Body Surface Area (BSA) greater than or equal to (\>=) 10 percentage (%) at screening and baseline
• Participant has a total Psoriasis Area and Severity Index (PASI) \>= 12 at screening and baseline
• Participant has a total Investigator's Global Assessment (IGA) \>= 3 at screening and baseline
• Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis

You may not qualify if:

• Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
• Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Participant have previously received any other therapeutic agent directly targeted to interleukin 23 (including but not limited to guselkumab, tildrakizumab, or risankizumab)
• Participant has received any therapeutic agent directly targeted to interleukin 17 (IL-17), interleukin 17 receptor (IL-17R) or interleukin 12/23 (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received biological therapy targeting tumor necrosis factor (TNF) (including, but not limited to adalimumab, infliximab, or etanercept) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention
• Participant has received proton pump inhibitors (including but not limited to omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, dexlansoprazole, or zegerid) within 1 week of first administration of study intervention

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (34)

Stoll Dermatology

Beverly Hills, California, 90212, United States

Location

Northshore University Healthsystem

Skokie, Illinois, 60077, United States

Location

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, 66210, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40241, United States

Location

Lawrence J Green MD LLC

Rockville, Maryland, 20850, United States

Location

ActivMed Practices and Research

Beverly, Massachusetts, 01915, United States

Location

ActivMed Practices and Research

Portsmouth, New Hampshire, 03801, United States

Location

Windsor Dermatology, PC

East Windsor, New Jersey, 08520, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania, 19341, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Dermatology Research Institute Inc

Calgary, Alberta, T2J 7E1, Canada

Location

The Guenther Dermatology Research Centre

London, Ontario, N6A 3H7, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

DermEdge Research

Mississauga, Ontario, L4Y 4C5, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

CHRU Brest - Hopital Morvan

Brest, 29200, France

Location

CHU de Grenoble Hopital Albert Michallon

La Tronche, 38700, France

Location

CHU de Nice Hopital de l Archet

Nice, 06200, France

Location

Polyclinique de Courlancy

Reims, 51100, France

Location

Hautarztpraxis

Bramsche, 49565, Germany

Location

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Privatpraxis Dr. Hilton & Partner

Düsseldorf, 40212, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitatsklinikum Schleswig Holstein Campus Lubeck

Lübeck, 23538, Germany

Location

Universitatsklinikum Munster

Münster, 48149, Germany

Location

Universitaetsmedizin Rostock

Rostock, 18057, Germany

Location

Specderm Poznanska sp j

Bialystok, 15 375, Poland

Location

Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

Krakow, 30 002, Poland

Location

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, 90-338, Poland

Location

Hosp. Univ. de Cruces

Barakaldo, 48902, Spain

Location

Hosp. Univ. San Cecilio

Granada, 18016, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Results Point of Contact

• Title: Global Medical Head Dermatology
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: June 13, 2022
• Primary Completion: March 23, 2023
• Study Completion: April 10, 2023
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (5); US (12); ES (3); DE (7); PL (3); FR (4)